NDC 51662-1219 Diphenhydramine Hydrochloride

Injection Intramuscular; Intravenous - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
51662-1219
Proprietary Name:
Diphenhydramine Hydrochloride
Non-Proprietary Name: [1]
Diphenhydramine Hydrochloride
Substance Name: [2]
Diphenhydramine Hydrochloride
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route(s): [4]
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
  • Labeler Name: [5]
    Hf Acquisition Co. Llc, Dba Health First
    Labeler Code:
    51662
    FDA Application Number: [6]
    ANDA080817
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    08-16-2018
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 51662-1219-1

    Package Description: 1 mL in 1 VIAL

    NDC Code 51662-1219-3

    Package Description: 25 POUCH in 1 CASE / 1 mL in 1 POUCH (51662-1219-2)

    Product Details

    What is NDC 51662-1219?

    The NDC code 51662-1219 is assigned by the FDA to the product Diphenhydramine Hydrochloride which is a human prescription drug product labeled by Hf Acquisition Co. Llc, Dba Health First. The product's dosage form is injection and is administered via intramuscular; intravenous form. The product is distributed in 2 packages with assigned NDC codes 51662-1219-1 1 ml in 1 vial , 51662-1219-3 25 pouch in 1 case / 1 ml in 1 pouch (51662-1219-2). This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Diphenhydramine Hydrochloride?

    Diphenhydramine Hydrochloride Injection is effective in adults and pediatric patients, other than premature infants and neonates, for the following conditions when the oral form is impractical:AntihistaminicFor amelioration of allergic reactions to blood or plasma, in anaphylaxis as an adjunct to epinephrine and other standard measures after the acute symptoms have been controlled and for other uncomplicated allergic conditions of the immediate type when oral therapy is impossible or contraindicated.Motion SicknessFor active treatment of motion sickness.AntiparkinsonismFor use in parkinsonism, when oral therapy is impossible or contraindicated, as follows: parkinsonism in the elderly who are unable to tolerate more potent agents, mild cases of parkinsonism in other age groups and in other cases of parkinsonism in combination with centrally acting anticholinergic agents.

    What are Diphenhydramine Hydrochloride Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
    • DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/mL - A histamine H1 antagonist used as an antiemetic, antitussive, for dermatoses and pruritus, for hypersensitivity reactions, as a hypnotic, an antiparkinson, and as an ingredient in common cold preparations. It has some undesired antimuscarinic and sedative effects.

    Which are Diphenhydramine Hydrochloride UNII Codes?

    The UNII codes for the active ingredients in this product are:

    • DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40)
    • DIPHENHYDRAMINE (UNII: 8GTS82S83M) (Active Moiety)

    Which are Diphenhydramine Hydrochloride Inactive Ingredients UNII Codes?

    The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

    What is the NDC to RxNorm Crosswalk for Diphenhydramine Hydrochloride?

    RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

    Which are the Pharmacologic Classes for Diphenhydramine Hydrochloride?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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    Patient Education

    Diphenhydramine Injection


    Diphenhydramine injection is used to treat allergic reactions, especially for people who are unable to take diphenhydramine by mouth. It is used also to treat motion sickness. Diphenhydramine injection is also used alone or along with other medications to control abnormal movements in people who have Parkinsonian syndrome (a disorder of the nervous system that causes difficulties with movement, muscle control, and balance). Diphenhydramine injection should not be used in newborn or premature infants. Diphenhydramine injection is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.
    [Learn More]


    * Please review the disclaimer below.

    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

    [8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

    [12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".